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A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

NCT07053423 · Sanofi
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Official title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.
About this study
LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.
Eligibility criteria
Inclusion Criteria: Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening: * Current or former smokers with a smoking history of ≥10 pack-years * Moderate-to-severe COPD (post-BD FEV1/FVC ratio \<0.70 and post-BD FEV1 % predicted \>30% and ≤70%) * Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10 * Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations * Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated * Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation). * Mucus score cutoff of ≥3 Exclusion Criteria: * A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma * Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts * Treatment with oxygen \>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period * Diagnosis of α-1 anti-trypsin deficiency * Any biologic therapy (including experimental treatments and dupilumab) * Participants on treatment with mucolytics unless on stable therapy for \>6 months The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study design
Enrollment target: 218 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-22
Estimated completion: 2029-02-15
Last updated: 2026-03-24
Interventions
Drug: DupilumabDrug: Placebo
Primary outcomes
  • Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) (Baseline to Week 24)
Sponsor
Sanofi · industry
With: Regeneron Pharmaceuticals
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (53)
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003Recruiting
Birmingham, Alabama, United States
Finlay Medical Research- Site Number : 8400010Recruiting
Miami, Florida, United States
Johns Hopkins Bayview Medical Center- Site Number : 8400009Recruiting
Baltimore, Maryland, United States
American Health Research - Charlotte- Site Number : 8400013Recruiting
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004Recruiting
Winston-Salem, North Carolina, United States
Clinical Research Associates of Central PA- Site Number : 8400002Recruiting
DuBois, Pennsylvania, United States
REX Clinical Trials - Beaumont- Site Number : 8400011Recruiting
Beaumont, Texas, United States
Investigational Site Number : 0320001Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320002Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320003Recruiting
Buenos Aires, Argentina
Associacao Proar- Site Number : 0760005Recruiting
Salvador, Estado de Bahia, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006Recruiting
São Paulo, Brazil
Incor - Instituto do Coracao- Site Number : 0760001Recruiting
São Paulo, Brazil
Investigational Site Number : 1560001Recruiting
Guangzhou, China
Investigational Site Number : 2080003Recruiting
Aalborg, Denmark
Investigational Site Number : 2080002Recruiting
Vejle, Denmark
Investigational Site Number : 2500008Recruiting
La Tronche, France
Investigational Site Number : 2500001Recruiting
Lille, France
Investigational Site Number : 2500005Recruiting
Lyon, France
Investigational Site Number : 2500006Recruiting
Marseille, France
Investigational Site Number : 2500002Recruiting
Montpellier, France
Investigational Site Number : 2500003Recruiting
Pessac, France
Investigational Site Number : 2500004Recruiting
Reims, France
Investigational Site Number : 3480003Recruiting
Debrecen, Hungary
Investigational Site Number : 3480001Recruiting
Hajdúnánás, Hungary
Investigational Site Number : 3480002Recruiting
Pécs, Hungary
Investigational Site Number : 3800001Recruiting
Cona, Ferrara, Italy
Investigational Site Number : 3800004Recruiting
Siena, Italy
Investigational Site Number : 5280001Recruiting
Groningen, Netherlands
Investigational Site Number : 5280003Recruiting
Hoofddorp, Netherlands
Investigational Site Number : 5280006Recruiting
Nijmegen, Netherlands
Investigational Site Number : 6160001Recruiting
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160003Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160002Recruiting
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 4100005Recruiting
Anyang-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100001Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240001Recruiting
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005Recruiting
Santander, Cantabria, Spain
Investigational Site Number : 7240002Recruiting
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240004Recruiting
Oviedo, Principality of Asturias, Spain
Investigational Site Number : 7240003Recruiting
Madrid, Spain
Investigational Site Number : 7520002Recruiting
Gothenburg, Sweden
Investigational Site Number : 7520003Recruiting
Lund, Sweden
Investigational Site Number : 1580001Recruiting
Kaohsiung City, Taiwan
Investigational Site Number : 1580002Recruiting
Taipei, Taiwan
Investigational Site Number : 8260006Recruiting
Newcastle upon Tyne, England, United Kingdom
Investigational Site Number : 8260008Recruiting
Southampton, Hampshire, United Kingdom
Investigational Site Number : 8260003Recruiting
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260001Recruiting
Bradford, United Kingdom